DOLPAC 25

Main information

  • Trade name:
  • DOLPAC 25
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOLPAC 25
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • praziquantel, combinations
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0183/003
  • Authorization date:
  • 19-05-2011
  • EU code:
  • FR/V/0183/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Vetoquinol/DOLPACLargedogs/EuropeanRenewal June2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Austria

Belgium

Cyprus

Malta

CzechRepublic

Netherlands

Greece

Portugal

Slovakia

Hungary

Slovenia

Germany

Finland Dolpaclargedogstablets

FranceLuxembourg

Dolpac25comprimé

UK-Ireland-Italy

DolpacTabletsforLargeDogs

PolandSpain Dolpaclargedogstabletsfor20-75

kg

Denmark

Sweden Dolpacvetlargedogstablets

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstances

Oxantel 500.70mg(equivalentto1397.5mgofoxantel

embonate)

Pyrantel 124.85mg(equivalentto360mgofpyrantelembonate)

Praziquantel 125.00mg

Excipienttoone2375mgdivisibletablet

Excipients

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Tablet

Paleyellowtoyellowoblongtabletwithbreakingline.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Forcurativetreatmentofdogsharbouringmixedparasiticinfestationswiththefollowingadultstages

ofnematodeandcestodespecies:

Nematodes:

Toxocaracanis

Toxascarisleonina

Ancylostomacaninum

Uncinariastenocephala

Trichurisvulpis

Vetoquinol/DOLPACLargedogs/EuropeanRenewal June2011

Cestodes:

Dipylidiumcaninum

Taeniaspp

Echinococcusmultilocularis

Echinococcusgranulosus

4.3 Contraindications

Seesection4.8

4.4 Specialwarningsforeachtargetspecies

Parasiteresistancetoanyparticularclassofanthelminticmaydevelopfollowingfrequent,repeated

useofananthelminticofthatclass

Fleasserveasintermediatehostsforoneofthecommontapeworms –Dipylidiumcaninum.

Tapeworminfestationmayreoccurunlesscontrolofintermediatehosts(fleas)isundertaken.

4.5 Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

RoundwormandHookworminfection:

Insomeanimals,AncylostomacaninumandToxocaracanismaynotbetotallyeradicatedbythe

treatment,resultinginacontinuedriskofeggsheddingintotheenvironment.Follow-upexaminations

ofthefaecesareadvisableandaccordingtotheresultsoftheseexaminations,treatmentwitha

nematodicidalproductmaybecarriedoutifnecessary.

Theproductisnotrecommendedforuseinpupsyoungerthantwomonthsoldorweighinglessthan

1kg.

Indebilitatedorheavilyinfestedanimals,theproductshouldbeusedonlyaccordingtoabenefit/risk

assessmentbytheresponsibleveterinarian.

Donotuseinanimalswithknownhypersensitivitytoanyofthecomponentsoftheproduct.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Someconstituentsofthisproductmaycauseallergicreactionsorskinirritation.

Avoidcontactwiththeskin.

Peoplewithknownhypersensitivitytoanyoftheingredientsshouldavoidcontactwiththisproduct.

Washhandsafteruse.

Incaseofaccidentalingestion,seekmedicaladviceandshowthepackageleaflettothephysician.

4.6 Adversereactions(frequencyandseriousness)

Vomitinganddiarrhoeamaybeobservedfollowingthetreatment.

Despitenotbeingobservedinstudiesperformedwiththeproduct,anorexiacanoccurasitisa

commonadverseeffectofproductscontainingpraziquantel.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancyand

lactation.Theuseisnotrecommendedduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusesimultaneouslywithlevamisole,piperazineorcholineesteraseinhibitors

4.9 Amountstobeadministeredandadministrationroute

Therecommendeddoserateis20mgoxantel/5mgpyrantel/5mgpraziquantelperkgbodyweight,

ieonetabletper25kgbodyweightinasingleintake,byoralroute.

Administertherequirednumberoftablets,accordingtobodyweight,orally,inasingleadministration.

Preferably,dogsshouldbefastedpriortotreatment.Foodmaybegivenonehourormoreafter

treatment.

Vetoquinol/DOLPACLargedogs/EuropeanRenewal June2011

Weightofdog Numberoftablets

From10.1to12.5kg ½

From12.6to25kg 1

From25.1to50kg 2

From50.1to75kg 3

Thetabletcanbedividedintohalves.

Dogskepttogetherorinkennelsshouldbetreatedatthesametime.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Administrationoftheproducttohealthydogsat5timestherecommendeddosagefor

6consecutiveweekshadnoadverseconsequences.

4.11 Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Praziquantel,combinations

ATCvetCode:QP52AA51

5.1 Pharmacodynamicproperties

Theproductcontainsthreeactiveingredients,pyrantelembonate,oxantelembonateand

praziquantel.Thespectrumofactivityoftheproductiswide,directedtowardsgastro-intestinal

roundworms(ascaris,whipwormandhookworms)andtapeworms.

Pyrantelhasaparalysingeffectonroundwormmuscles,byactivatingacetylcholinereceptors.Its

activityismoreparticularlydirectedagainstToxocaracanis,Toxascarisleonina,Uncinaria

stenocephalaandAncylostomacaninum.ItsactivityagainstTrichurisvulpisisnegligible.

Oxantelisanm-oxyphenolicderivateofpyrantel,thathasbeendevelopedforitsactivityagainst

whipworms.

Praziquantelleadstomuscularcontractions,paralysisandalteredparasitetegumentintegrity.Itis

activeagainstadultsandlarvalstagesofdogtapeworms,Echinococcus,TaeniaandDipylidium.

5.2 Pharmacokineticparticulars

Afteroraladministration,theabsorptionofoxantelembonateisnegligible.Pyrantelisquickly

absorbedbutinsmallquantities(T

max =1.38h,C

=0.048µg/ml)andisveryquicklyeliminated.

Praziquantelisquicklyabsorbed(T

max =1.28h,C

=0.4µg/ml)andeliminated(eliminationhalf-life

1.5h).

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Dextrates

PovidoneK30

Sodiumlaurylsulphate

Baconflavour

Crospovidone

Sodiumstearylfumarate

6.2 Incompatibilities

Noneapplicable

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:threeyears

Discardanyunusedhalftablet

6.4. Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Vetoquinol/DOLPACLargedogs/EuropeanRenewal June2011

6.5 Natureandcompositionofimmediatepackaging

Polyamide-aluminium-PVC/aluminiumblisterorpolychlorotrifluoroethylene-PVC/aluminiumblister

stripof3tablets.

Cardboardboxwith1stripof3tablets

Cardboardboxwith6stripsof3tablets

Cardboardboxwith10stripsof3tablets

Cardboardboxwith20stripsof3tablets

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE-

Vetoquinol/DOLPACLargedogs/EuropeanRenewal June2011